Clinical trial · Interventional
Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography
NCT02615509CI-TRIAL-00045011terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Discontinuation of development of device.
Summary
Brief summary (as posted)
The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging on experimental tomo device | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Imaging on experimental tomo device
- description
- Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised. After collecting the cases together with ground truth a readers study will be performed.
- interventionNames
- Radiation: Imaging on experimental tomo device
Primary outcomes (1)
- measure
- To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.
- timeFrame
- Up to approximately 4 weeks.
- description
- Due to study termination the conventional images where not taken and it was not possible to calculate the Area under the Receiver Operating Characteristics Curve. Instead we are reporting the biopsy results from the Philips MicroDose Tomosynthesis system. The time frame from examination to biopsy is documented as an estimate based on the relative urgency to detect potential tumors.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is female and at least 40 years of age * No contraindication for routine bilateral mammography Screening Cohort * Patient presents for a routine screening mammogram Biopsy Cohort * Patient is scheduled for a biopsy * Patient has a screening detected abnormality Exclusion Criteria: * Patient is pregnant or believes she may be pregnant; OR, * Patient is breast feeding; OR * Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR, * Patient has breast implants; OR * Patient has previous surgical biopsy; OR * Patient has previous breast cancer; OR * Patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)
References
Publications (0)
Data not yet available
No reference posted for this study.